SCHEDULES

SCHEDULE 2Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

PART 6Amendment of Part 7 (amendment of Part 7 (Traditional Herbal Registrations))

97

For regulation 129 (amendment of regulation 146 (obligation in relation to product information)) substitute—

129

For regulation 146(2), substitute—

2

In this regulation “current scientific knowledge” includes the conclusions of the assessment and recommendations made public by means of—

a

in the case of a medicinal product for sale or supply in Northern Ireland—

i

the European medicines web-portal established in accordance with Article 26 of Regulation (EC) No 726/2004, and

ii

the UK web-portal established in accordance with regulation 203(1);

b

in the case of a medicinal product for sale or supply in Great Britain only, the UK web-portal established in accordance with regulation 203(1).